Representatives from the FDA voted to relax restrictions on the drug rosiglitazone - brand name Avandia - after producers GlaxoSmithKline were able to affirm its relative safety as a medical treatment for type-2 diabetes sufferers.

The initial restrictions were placed after a 2007 article in the New England Journal of Medicine by Dr Steven Nissen had uncovered a study which pointed to Avandia’s link to 47,000 cases of cardiovascular problems apparently suffered while taking the drug between 1999 and 2009. It warns that people who take the drug suffer a 43% increase in the risk of heart attacks.

Despite this study, and other studies which have actually noted Avandia’s underwhelming performance even without the other health risks, the FDA allowed GSK to keep it on the market until the makers’ own research could be complete and presented to the appropriate authorities.

An FDA panel voted last month to relax the restrictions it had placed on the drug which allowed it only to be prescribed and sold by specially-certified doctors and pharmacists, and only to be given to patients who had exhausted every other option of treatment, and were otherwise aware of the inherent risks of taking Avandia. The drug will now branch back out into a more general market despite its black-box warning given in 2007, which is legally required by the FDA to be placed on any product with sufficient risk of adverse side effects.

Once proven as a dangerous drug if not appropriately regulated, the legal ramifications were severe for GSK – particularly the $3bn fine they paid to settle the federal criminal charges for failing to report some of their clinical trial data to the proper authorities – for Avandia and two other medications. GSK have since gone on to settle lawsuits with some 16,000 applicants in the United States at a total cost of $770 million – about $46,000 per claimant.

The situation Stateside is made to look even more baffling given the drug’s complete ban in the UK and Europe, after the British Medical Journal recommended not only its immediate withdrawal from sale, but that it should never have been sold in the first place given its benefits are far outweighed by its risks. In the UK, legal medical injury cases are also beginning to be heard against GSK by law firm Express Solicitors, adding to the pressure for GSK as they try to prove the comparative risks of Avandia.